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In the intent-to-treat population (ITT, all randomized patients), solithromycin met the FDA primary objective of statistical non-inferiority (NI, 10% non-inferiority margin) compared to moxifloxacin at the early clinical response (ECR, 72 [-12/+36] hours after initiation of therapy). The point estimates for the primary endpoint of early clinical response were 79.3% for solithromycin and 79.7% for moxifloxacin. The 95% confidence interval for the treatment difference had lower and upper bounds of -6.1% and 5.2%, respectively.

Solithromycin also met the co-primary objective of statistical NI compared to moxifloxacin at the ECR in the microbiological ITT (mITT) population (those patients with an etiologic diagnosis of the cause of CABP) from the pooled data from both Phase 3 studies. The point estimates were 77.2% for solithromycin and 78.9% for moxifloxacin with lower and upper bounds of the 95% confidence interval for the treatment difference of -7.4% and 4.2%.

Solithromycin also met the secondary endpoint of NI compared to moxifloxacin in the mITT population at the ECR time point from Solitaire-IV alone. The point estimates for this endpoint were 80.3% for solithromycin and 79.1% for moxifloxacin with lower and upper bounds of the 95% confidence interval for the treatment difference of -8.1% and 10.6%.

Additional secondary endpoints evaluated solithromycin at the short term follow up visit (SFU) 5-10 days after therapy in both the ITT and clinically evaluable (CE) populations. Clinical success rates as determined by investigators at the SFU visit were high for both the solithromycin and moxifloxacin groups in the ITT population with point estimates of 84.6% and 88.7%, respectively. Clinical success rates were also high in the CE-SFU population for both the solithromycin and moxifloxacin groups, with point estimates of 86.4% and 92.8%, respectively. This CE outcome was skewed in favor of moxifloxacin by a blinded drug supply shortage which led to discontinuation of study drug in solithromycin patients only. Censoring these 5 patients, all of which fell on the solithromycin side, results in point estimates for CE population success at the SFU visit of 87.6% for solithromycin patients.

The primary endpoint for the European Medicines Agency (EMA) was NI in the ITT and the CE-SFU populations limited to patients with PORT III/IV CABP at the SFU time point. Solithromycin was non-inferior to moxifloxacin in the ITT-SFU population. As well, solithromycin would be NI to moxifloxacin in the CE-SFU population after censoring those patients from the CE population who had early discontinuation of blinded study drug due to supply issues.

The FDA has granted Fast Track designation for solithromycin IV and capsules for the treatment of CABP. The agency has also designated solithromycin IV and capsules for the treatment of CABP and solithromycin capsules for the treatment of gonorrhea as a Qualified Infectious Disease Product (QIDP).

"The positive results of our solithromycin Phase 3 program in the treatment of CABP, first using oral capsules and now with the IV formulation, which included a switch to oral capsules, are a remarkable achievement for Cempra. I would like to express my sincere gratitude to all of the patients and physicians that participated in these important studies," stated Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. "The ability to treat patients in the hospital with solithromycin IV and switch them to an oral formulation of the same antibiotic may allow for earlier patient discharge from the hospital and result in cost savings. We believe that solithromycin's potency, spectrum, safety and efficacy could provide a new antibiotic treatment option that is urgently needed to offset the rising problem of bacterial resistance. I am delighted to announce that we will now be moving forward with solithromycin's NDA submission...